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A multicenter randomized phase III trial to compare weekly usage with triweekly usage of docetaxel and cisplatin in concurrent chemoradio-therapy for patients with locally advaced non-small cell lun

A multicenter randomized phase III trial to compare weekly usage with triweekly usage of docetaxel and cisplatin in concurrent chemoradio-therapy for patients with locally advaced non-small cell lun

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-10000774
Enrollment
Unknown
Registered
2010-01-30
Start date
2009-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced non-small cell lung cancer

Interventions

1:The concurrent chemotherapy consisted of Docetaxel 60 mg/m2, on day 1 and Cisplatin 30mg/m2 , on day 1 and day 2, repeated every three weeks for a total of six weeks. Consolidation chemotherapy were
2:The concurrent chemotherapy consisted of Docetaxel and Cisplatin 20mg/m2 , on day 1, repeated every week for a total of six weeks. The same consolidation chemotherapy regime as A.

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically confirmed unresectable stage IIIA or stage IIIB non-small cell lung; 2. At least 1 bidimensionally or unidimensionally measurable lesion less than 8cm; 3. Age: 18-70 years old; 4. Histologically or cytologically confirmed unresectable stage IIIA or stage IIIB non-small cell lung; 5. At least 1 bidimensionally or unidimensionally measurable lesion less than 8cm. 6. no more than 10% weight loss within past 6 months, life expectancy >12 months and tolerent radiation; 7. No chest RT history and no other treatment for cancer in the last month; 8. The ECOG 0-1; 9. No main organ function disable, Leucocyte>= 4000/uL, a neutrophil count>=1500/uL, PLT >=10000/uL, hemoglobin>=10g/dL, CR=1.5 L and >50% upper limit of normal; 11. Patients shoud understand and sign the Informed consent.

Exclusion criteria

Exclusion criteria: 1. Carcinoid tumors and small cell lung cancer; 2. Patients are receiving other anti-cancer therapy, and pregnant and lactating women; 3. Patients with a second primary tumor other than non-melanoma skin cancer or in situ cervical carcinoma; 4. Any chemotherapy contraindications such as active infection, uncontrolled diabetes, prior allergic reaction to docetaxel and other serious disease, for example myocardial infarction; 5. Uncontrolable madman psychopath; 6. Investigator consider inappropriate patients for the study.

Design outcomes

Primary

MeasureTime frame
PFS, 2 and 5 year OS, MS;

Secondary

MeasureTime frame
Response rate and toxicity;

Countries

China

Contacts

Public ContactGuangying Zhu
zgypu@yahoo.com.cn+86 010 88196120

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026